Cochlear ImplantNCT07821281
Epidemiological Survey on the Current Status of Cochlear Implantation in China
An observational study of Cochlear Implant and Severe to Very Severe Sensorineural Hearing Loss, run by Chinese PLA General Hospital.
Trial summary
Cochlear implantation is an effective intervention for patients with severe to very severe sensorineural hearing loss. By the beginning of 2026, the total number of cochlear implants in China was about 180000. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cochlear Implant, Severe to Very Severe Sensorineural Hearing Loss
- What is being tested?
- Cochlear Implant
- How many people
- 180,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1995to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe/very severe sensorineural hearing loss.
Who may be able to join
- Patients who received cochlear implants in Chinese medical institutions between 1995 and 2026;
- Patients with preoperative diagnosis of severe/very severe sensorineural deafness;
- Implantation age ≥ 6 months;
- Records containing at least gender, date of birth, date of surgery, domicile, surgical area, type of implant surgery (first unilateral implant/first bilateral implant/first contralateral implant/re-implant) and implant model information.
Who cannot join
- Lack of key information;
- Other devices such as auditory brainstem implants (ABI) or middle ear implants.
About this study
Official title: China Cochlear Implant for 30 Years: Epidemiology, Policy Effects and Health Economics Evaluation of Cochlear Implantation in China
Cochlear implantation is an effective intervention for patients with severe to very severe sensorineural hearing loss. By the beginning of 2026, the total number of cochlear implants in China was about 180000. According to the World Health Organization (WHO) survey and data released by the National Bureau of Statistics of China, it is estimated that China's population with severe hearing loss is about 11 million, and the penetration rate is only 1.55. Among them, the adult penetration rate is particularly insufficient, which is far lower than the level of developed countries. In recent years, policy dividends have been intensively introduced in various parts of China. With the update of the rehabilitation service catalog, the price of a single set of cochlear implants in China has plummeted, and cochlear implants have progressed rapidly. At this historical turning point, a systematic analysis of the epidemiology of cochlear implants in my country Characteristics, policy effects and health economics benefits are of great significance for optimizing resource allocation and formulating national hearing care strategies.
Read the detailed description
The data of this study mainly include basic demographic information, clinical and surgical information, implant product information, regional information and external macro data of cochlear implant patients. Patient-level data include gender, date of birth, date of operation, age of implantation, place of residence, area of operation, type of implantation, type of implant and manufacturer, etc. Regional-level data include population size, age structure, economic development level, per capita disposable income of residents, allocation of medical resources, medical insurance policy, centralized procurement policy, CDPF subsidy policy and coverage of rehabilitation service catalogue in each province; the burden of disease and health economics parameters include the prevalence of severe/very severe hearing loss, disability weight, quality of life utility value, medical expenses, rehabilitation costs, care costs and productivity losses.
Statistical analysis begins with cleaning, de-duplication, missing value processing and logical verification of the original data, and unifying the coding of variables such as region, age, gender, implant type and product model. Descriptive statistical methods were used to analyze the age, gender, region, implant time, implant type and product source distribution of cochlear implant patients in China and provinces from 1995 to 2026, and to describe the change trend of cochlear implant volume, implant rate and penetration rate.
On this basis, combined with the population data of the National Bureau of Statistics of China and the prevalence of severe/extremely severe hearing loss published by the World Health Organization (WHO) or related studies, the cochlear implant penetration rate of different age groups and different genders in the country and provinces is estimated, and the differences between different regions and different populations are compared. The impact of economic and policy factors on the volume and penetration of cochlear implants is further analyzed, taking into account the economic level, medical resources, medical insurance payment, collection policy, CDPF subsidy and rehabilitation service coverage in each region.
For the impact of important policies and major events, we will compare the changes in the number, regional distribution, age structure and product structure of cochlear implants before and after the event, and assess the impact of policies or public health events on the accessibility of cochlear implant services.
In the aspect of health economics analysis, it is proposed to evaluate the disease burden and health benefits of cochlear implant by combining the direct medical cost, rehabilitation cost, care cost, productivity loss, disability lost life year (YLD), disability adjusted life year (DALY) and quality of life improvement caused by severe/very severe deafness. The Markov model is further constructed to simulate the transfer between different health states of patients with cochlear implant and non-implanted or conventional hearing aid intervention, and to measure the cost, health benefit and cost effect of cochlear implant in the whole life cycle, which provides the basis for medical insurance payment, government health resource allocation and hearing health intervention policy.
- Being tested
- Cochlear Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear ImplantOther
Chinese cochlear implant patients from 1995 to 2026
| Study group | Role | What they receive |
|---|---|---|
| Chinese cochlear implant patients from 1995 to 2026. | Not described Receives: Other: Cochlear Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trends in disease burden of severe/very severe deafness in China and provinces
Based on the data of Chinese cochlear implants, combined with the population with severe hearing loss, the total penetration rate of cochlear implants in China and the trend of changes over the years were calculated.
The patients were grouped according to the age at the time of operation.The proportion of each age group in the total population, the change trend of age distribution and gender distribution characteristics were calculated respectively.
To construct the medical flow of patients in the provinces of household registration and surgery, Compare the changes in the provincial retention rate and cross-provincial flow of cochlear surgery in China and provinces before and after the collection and medical insurance policy.
Set different cochlear implant coverage scenarios, calculate the new demand for the number of surgeries currently completed under the target, quantify the potential service gap, and provide a preliminary planning reference for future cochlear implant services.
Measured: from 1995 to 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Jan 1995
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 180,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiming Yang, PhD, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821281
- Sponsor's protocol ID
- CIBD2026
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Cochlear Implant for 30 Years: Epidemiology, Policy Effects and Health Economics Evaluation of Cochlear Implantation in China
- ClinicalTrials.gov ID
- NCT07821281
- Acronym / sponsor ID
- CIBD2026
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180,000 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 1995 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cochlear implantation is an effective intervention for patients with severe to very severe sensorineural hearing loss. By the beginning of 2026, the total number of cochlear implants in China was about 180000. According to the World Health Organization (WHO) survey and data released by the National Bureau of Statistics of China, it is estimated that China's population with severe hearing loss is about 11 million, and the penetration rate is only 1.55. Among them, the adult penetration rate is particularly insufficient, which is far lower than the level of developed countries. In recent years, policy dividends have been intensively introduced in various parts of China. With the update of the rehabilitation service catalog, the price of a single set of cochlear implants in China has plummeted, and cochlear implants have progressed rapidly. At this historical turning point, a systematic analysis of the epidemiology of cochlear implants in my country Characteristics, policy effects and health economics benefits are of great significance for optimizing resource allocation and formulating national hearing care strategies.
Detailed description
The data of this study mainly include basic demographic information, clinical and surgical information, implant product information, regional information and external macro data of cochlear implant patients. Patient-level data include gender, date of birth, date of operation, age of implantation, place of residence, area of operation, type of implantation, type of implant and manufacturer, etc. Regional-level data include population size, age structure, economic development level, per capita disposable income of residents, allocation of medical resources, medical insurance policy, centralized procurement policy, CDPF subsidy policy and coverage of rehabilitation service catalogue in each province; the burden of disease and health economics parameters include the prevalence of severe/very severe hearing loss, disability weight, quality of life utility value, medical expenses, rehabilitation costs, care costs and productivity losses.
Statistical analysis begins with cleaning, de-duplication, missing value processing and logical verification of the original data, and unifying the coding of variables such as region, age, gender, implant type and product model. Descriptive statistical methods were used to analyze the age, gender, region, implant time, implant type and product source distribution of cochlear implant patients in China and provinces from 1995 to 2026, and to describe the change trend of cochlear implant volume, implant rate and penetration rate.
On this basis, combined with the population data of the National Bureau of Statistics of China and the prevalence of severe/extremely severe hearing loss published by the World Health Organization (WHO) or related studies, the cochlear implant penetration rate of different age groups and different genders in the country and provinces is estimated, and the differences between different regions and different populations are compared. The impact of economic and policy factors on the volume and penetration of cochlear implants is further analyzed, taking into account the economic level, medical resources, medical insurance payment, collection policy, CDPF subsidy and rehabilitation service coverage in each region.
For the impact of important policies and major events, we will compare the changes in the number, regional distribution, age structure and product structure of cochlear implants before and after the event, and assess the impact of policies or public health events on the accessibility of cochlear implant services.
In the aspect of health economics analysis, it is proposed to evaluate the disease burden and health benefits of cochlear implant by combining the direct medical cost, rehabilitation cost, care cost, productivity loss, disability lost life year (YLD), disability adjusted life year (DALY) and quality of life improvement caused by severe/very severe deafness. The Markov model is further constructed to simulate the transfer between different health states of patients with cochlear implant and non-implanted or conventional hearing aid intervention, and to measure the cost, health benefit and cost effect of cochlear implant in the whole life cycle, which provides the basis for medical insurance payment, government health resource allocation and hearing health intervention policy.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese cochlear implant patients from 1995 to 2026. | – | Other: Cochlear Implant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe/very severe sensorineural hearing loss.
Key inclusion criteria (4 listed)
- Patients who received cochlear implants in Chinese medical institutions between 1995 and 2026;
- Patients with preoperative diagnosis of severe/very severe sensorineural deafness;
- Implantation age ≥ 6 months;
- Records containing at least gender, date of birth, date of surgery, domicile, surgical area, type of implant surgery (first unilateral implant/first bilateral implant/first contralateral implant/re-implant) and implant model information.
Key exclusion criteria (2 listed)
- Lack of key information;
- Other devices such as auditory brainstem implants (ABI) or middle ear implants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear ImplantChinese cochlear implant patients from 1995 to 2026 | Other | Chinese cochlear implant patients from 1995 to 2026. |
Primary outcome
Trends in disease burden of severe/very severe deafness in China and provinces
Time frame: from 1995 to 2026
Based on the data of Chinese cochlear implants, combined with the population with severe hearing loss, the total penetration rate of cochlear implants in China and the trend of changes over the years were calculated. The patients were grouped according to the age at the time of operation.The proportion of each age group in the total population, the change trend of age distribution and gender distribution characteristics were calculated respectively. To construct the medical flow of patients in the provinces of household registration and surgery, Compare the changes in the provincial retention rate and cross-provincial flow of cochlear surgery in China and provinces before and after the collection and medical insurance policy. Set different cochlear implant coverage scenarios, calculate the new demand for the number of surgeries currently completed under the target, quantify the potential service gap, and provide a preliminary planning reference for future cochlear implant services.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Implant and Severe to Very Severe Sensorineural Hearing Loss, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trends in disease burden of severe/very severe deafness in China and provinces (time frame: from 1995 to 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.